Access to new drugs in low-and middle-income countries has been made easier through various public health initiatives. Many of these treatments have the potential to save and improve the quality of many lives, but the introduction of new drugs may result in previously unanticipated events and adverse reactions. Countries do not always have the capacity to effectively monitor the safety of those new drugs.
This is of particular concern with medications that are being introduced through an accelerated approval process, well before all phases of clinical trials have been completed and where there is only limited safety information. Pharmacovigilance (PV) and the management of adverse drug reactions are essential when introducing such fast-tracked, new medications. Pathway 3 of the Access and Delivery Partnership (ADP) focuses on strengthening health sector capacities in focus countries to monitor and respond to safety issues of newly introduced health technologies.
Bedaquiline (BDQ) is a new medication for the treatment of multidrug resistant TB (MDR-TB) and has received accelerated marketing approval in Europe and the United States. The national TB programme in Indonesia has planned to introduce BDQ in few pilot sites in 2015. As part of the preparation for the introduction of BDQ, the ADP has started working with the National Agency of Drug and Food Control / Badan POM (NADFC/BPOM), to improve pharmacovigilance capacity in the country. The aim, in particular, is to strengthen capacity for active surveillance of drugs such as BDQ to ensure early detection and proper management of adverse drug reactions.
To respond to the clear need expressed by the country, a 3-day workshop was organized on 28-30 April 2015 in collaboration between NADFC/BPOM and WHO as part of the ADP project activities in Indonesia.
The workshop aimed to strengthen PV and networking between PV staff and public health programmes, build PV capacity and introduce the principles of cohort event monitoring, an active pharmacovigilance method developed by the WHO Department of Essential Medicines and Health Products. The workshop was also an opportunity to review basic PV concepts and principles, with a view to strengthening key technical areas in PV in Indonesia.
There were approximately 40 participants and the workshop consisted of: academics (from the main universities in Indonesia), NADFC/BPOM staff, health-care professionals from hospitals, staff from provincial health offices (Jakarta, East and West Java), staff from NGOs, members of WHO Indonesia country office, and staff working under the ministry of health from the national TB, HIV and Malaria Programmes, and the Directorate of Pharmaceutical Services. Representatives from the WHO collaborating centre for Advocacy and Training in Pharmacovigilance in Accra, Ghana, staff from WHO HQ (Geneva) and a PV specialist from the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria presented and facilitated the workshop activities.
From the participants’ feedback, the workshop achieved its objectives of improving basic knowledge and technical capacity for PV in the country. It also provided an opportunity to strengthen collaborations between the public health programmes and the national PV centre in Indonesia and build capacity for active monitoring that will be needed for active safety monitoring of BDQ.
The national priority of introducing BDQ provided an entry point for the ADP to support relevant stakeholders on developing and utilizing the tools for active surveillance of not only BDQ but also of other innovative medicines that will be entering the market in the future.